# Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

For Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period, agency is HHS; maximum penalty is 1,510,803, recorded from its source on 2026-08-10.

- **Agency:** HHS _(our reading, not quoted from the source)_
- **Violation:** Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period _(verified: appears in the quote below)_
- **Maximum penalty:** 1,510,803 _(verified: appears in the quote below)_

## What the source says

> | | FDA | Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period | 2024 | 1,472,546 | 1,510,803

## Source

- https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3

Last verified: 2026-08-10. Review by: 2027-02-26.
Part of [Federal civil penalty maximums — current inflation-adjusted amounts across agencies](https://referencesource.org/federal-civil-penalty-maximums/).